• Regulatory NewsRegulatory News

    Health Canada Updates Bioavailability Requirements for Highly Variable Drugs

    Health Canada on Monday unveiled new comparative bioavailability requirements for drugs exhibiting large pharmacokinetic within-subject variation in terms of absorption. Although highly variable drugs are generally safe, the Canadian regulator says, the bioequivalence of their formulations is a problem because high variability means that large numbers of subjects are required to give adequate statistical power. In addition, highly variable drugs are poor quality formul...
  • Regulatory NewsRegulatory News

    New FDA Guidance Explains how to Test Drugs on Pediatric Patients

    A new guidance document issued by the US Food and Drug Administration (FDA) established new recommendations for how companies should conduct pediatric studies on new drug and biological products. Testing products in pediatric patients is notoriously difficult. As FDA regulators have reiterated on numerous occasions, children "are not just small adults ," and drug and biological products can behave much differently in pediatric patients compared to how they behave in...
  • FDA Signs Off on Par Pharma's Bioequivalence Study on Generic Wellbutrin Even as Questions Remain

    The US Food and Drug Administration (FDA) has approved a supplemental Abbreviated New Drug Application (sNDA) sponsored by Par Pharmaceuticals for a 300 mg, extended-release version of the popular antidepressant Wellbutrin XL (bupropion). The approval appears to be the first since the agency formally withdrew a nearly identical drug from the market several months ago after the product was found to not be bioequivalent to the reference listed drug (RLD). Background In Se...
  • A Generic Conundrum: How do you Study a Drug that has Been Withdrawn from the Market?

    In March 2013, the US Food and Drug Administration (FDA) formally withdrew approval for Impax Laboratory's buproprion hydrochloride extended release 300 mg (Budeprion XL 300 mg), saying the drug had been found to not be bioequivalent to its reference listed drug, Wellbutrin XL 300 mg. Soon thereafter, the agency announced it was looking for a company to further study the issue of why Impax's drug wasn't bioequivalent when several other generic products did not exhibit sim...
  • Feature ArticlesFeature Articles

    Biosimilars Breaching Borders: How FDA and EMA Find Common Ground

    Human clinical pharmacology, pharmacokinetic (PK) and pharmacodynamic (PD) studies are vital for many reasons, and uniquely useful in extrapolating the efficacy and safety of biosimilars. PK and PD studies are the most objective clinical trials, and are sensitive to changes in a drug product. But the workings and concepts behind such studies are not well understood by many in industry, and even physicians, in comparison with clinical efficacy. This article presents a E...